Modular multibranch stent assembly and method

ABSTRACT

A stent graft assembly including a main body and a branch coupling extending radially from the main body. A proximal end of the single branch stent device is configured to seal in an ascending portion of an aorta. The assembly further includes a modular stent device including a proximal end and a distal end. The proximal end of the modular stent graft is configured to couple to a distal end of the single branch stent device. The modular stent device includes a main body configured to couple inside the main body of the single branch stent device. The modular stent device includes a bypass gate and an artery leg. The modular stent device is configured to bifurcate at a bifurcation point from the main body to the bypass gate and the artery leg outside of and distal the distal end of the single branch stent device.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.17/517,593, filed Nov. 2, 2021, which is a divisional of U.S. patentapplication Ser. No. 16/554,813, filed Aug. 29, 2019, and issued as U.S.Pat. No. 11,191,633 on Dec. 7, 2021, which is incorporated herein byreference in its entirety.

TECHNICAL FIELD

The present technology is generally related to an intra-vascular deviceand method. More particularly, the present application relates to adevice for treatment.

BACKGROUND

Aneurysms, dissections, penetrating ulcers, intramural hematomas and/ortransections may occur in blood vessels, and most typically occur in theaorta and peripheral arteries. The diseased region of the aorta mayextend into areas having vessel bifurcations or segments of the aortafrom which smaller “branch” arteries extend.

The diseased region of the aorta can be bypassed by use of a stent-graftplaced inside the vessel spanning the diseased portion of the aorta, toseal off the diseased portion from further exposure to blood flowingthrough the aorta.

The use of stent-grafts to internally bypass the diseased portion of theaorta is not without challenges. In particular, care must be taken sothat critical branch arteries are not covered or occluded by thestent-graft yet the stent-graft must seal against the aorta wall andprovide a flow conduit for blood to flow past the diseased portion.

SUMMARY

In one embodiment, a stent graft assembly including a main body and abranch coupling extending radially from the main body is disclosed. Aproximal end of the single branch stent device is configured to seal inan ascending portion of an aorta. The assembly further includes amodular stent device including a proximal end and a distal end. Theproximal end of the modular stent graft is configured to couple to adistal end of the single branch stent device. The modular stent deviceincludes a main body configured to couple inside the main body of thesingle branch stent device. The modular stent device includes a bypassgate and an artery leg. The modular stent device is configured tobifurcate at a bifurcation point from the main body to the bypass gateand the artery leg outside of and distal the distal end of the singlebranch stent device.

In another embodiment, a method is disclosed. The method includesintroducing a single branch stent device via femoral access. The methodfurther includes advancing the single branch into the ascending aorta.The method also includes deploying the single stent device. The methodincludes introducing a modular stent device via access through an arterydistal of the brachiocephalic artery. The method also includes advancingthe modular stent device such that a main body of the modular stentdevice is located within the main body of the single branch stentdevice. The method also includes deploying the modular stent device suchthat the main body of the modular stent device bifurcates at abifurcation point to the bypass gate and the artery leg outside of anddistal the distal end of the single branch stent device.

The details of one or more aspects of the disclosure are set forth inthe accompanying drawings and the description below. Other features,objects, and advantages of the techniques described in this disclosurewill be apparent from the description and drawings, and from the claims.

BRIEF DESCRIPTION OF DRAWINGS

FIG. 1 is a cross-sectional view of a vessel assembly including a singlebranch stent device after deployment in accordance with one embodiment.

FIG. 2 is a cross-sectional view of the vessel assembly of FIG. 1 at alater stage during deployment of a bridging stent graft in accordancewith one embodiment.

FIG. 3 is a side plan view of a modular stent device in accordance withone embodiment.

FIG. 4 is a perspective view of the modular stent device of FIG. 3 inaccordance with one embodiment.

FIG. 5 is a cross-sectional view of the vessel assembly of FIG. 2 at alater stage during deployment of the modular stent device of FIGS. 3 and4 in accordance with one embodiment.

FIG. 6 is a cross-sectional view of the vessel assembly of FIG. 5 at afinal stage during deployment of a tube graft into the modular stentdevice and a proximal cuff into the single branch stent device inaccordance with one embodiment.

FIG. 7 is a cross-sectional view of the vessel assembly of FIG. 2 at alater stage during deployment of the modular stent device of FIGS. 3 and4 in accordance with another embodiment.

FIG. 8 is a cross-sectional view of the vessel assembly of FIG. 7 at afinal stage during deployment of a tube graft into the modular stentdevice and a proximal cuff into the single branch stent device inaccordance with one embodiment.

FIG. 9 is a side plan view of a modular stent device in accordance withanother embodiment.

FIG. 10 is a perspective view of the modular stent device of FIG. 9 inaccordance with one embodiment.

FIG. 11 is a cross-sectional view of the vessel assembly of FIG. 2 at alater stage during deployment of the modular stent device of FIGS. 9 and10 in accordance with another embodiment.

FIG. 12 is a cross-sectional view of the vessel assembly of FIG. 11 at alater stage during deployment of a bridging stent graft in accordancewith one embodiment.

FIG. 13 is a cross-sectional view of the vessel assembly of FIG. 12 at afinal stage during deployment of a tube graft into the modular stentdevice and a proximal cuff into the single branch stent device inaccordance with one embodiment.

FIG. 14 is a cross-sectional view of the vessel assembly of FIG. 11 at alater stage during deployment of a bridging stent graft in accordancewith another embodiment.

FIG. 15 is a cross-sectional view of the vessel assembly of FIG. 14 at afinal stage during deployment of a tube graft into the modular stentdevice and a proximal cuff into the single branch stent device inaccordance with one embodiment.

FIG. 16 is a cross-sectional view of a vessel assembly similar to thevessel assembly of FIG. 6 in accordance with another embodiment.

FIG. 17 is a cross-sectional view of a region of the vessel assembly ofFIG. 2 with a branch coupling misaligned with the brachiocephalic arteryin accordance with one embodiment.

DETAILED DESCRIPTION

FIG. 1 is a cross-sectional view of a vessel assembly 100 including asingle branch stent device 102 after deployment in accordance with oneembodiment. Referring to FIG. 1 , the thoracic aorta 104 has numerousarterial branches. The arch AA of the aorta 104 has three major branchesextending therefrom, all of which usually arise from the convex uppersurface of the arch AA. The brachiocephalic artery BCA originatesanterior to the trachea. The brachiocephalic artery BCA divides into twobranches, the right subclavian artery RSA (which supplies blood to theright arm) and the right common carotid artery RCC (which supplies bloodto the right side of the head and neck).

The left common carotid artery LCC arises from the arch AA of the aorta104 just distal of the origin of the brachiocephalic artery BCA. Theleft common carotid artery LCC supplies blood to the left side of thehead and neck. The third branch arising from the aortic arch AA, theleft subclavian artery LSA, originates behind and just to the left ofthe origin of the left common carotid artery LCC and supplies blood tothe left arm. The left subclavian artery LSA and the left common carotidartery LCC are distal to the brachiocephalic artery BCA and aresometimes called aortic branch arteries distal of the brachiocephalicartery BCA.

However, a significant proportion of the population has only two greatbranch vessels coming off the aortic arch AA while others have fourgreat branch vessels coming of the aortic arch AA. Accordingly, althougha particular anatomical geometry of the aortic arch AA is illustratedand discussed, in light of this disclosure, those of skill in the artwill understand that the geometry of the aortic arch AA has anatomicalvariations and that the various structures as disclosed herein would bemodified accordingly.

Aneurysms, dissections, penetrating ulcers, intramural hematomas and/ortransections, generally referred to as a diseased region of the aorta104, may occur in the aorta arch AA and the peripheral arteries BCA,LCC, LSA. For example, thoracic aortic aneurysms include aneurysmspresent in the ascending thoracic aorta, the aortic arch AA, and one ormore of the branch arteries BCA, LCC, LSA that emanate therefrom.Thoracic aortic aneurysms also include aneurysms present in thedescending thoracic aorta and branch arteries that emanate therefrom.Accordingly, the aorta 104 as illustrated in FIG. 1 has a diseasedregion similar to any one of those discussed above which will bebypassed and excluded using single branch stent device 102 as discussedbelow.

Single branch stent device 102, sometimes called a prosthesis or aorticarch prosthesis, includes a main body 106 and a branch coupling 108.Branch coupling 108 is sometimes called a volcano.

In accordance with this embodiment, main body 106 includes a main bodyproximal opening 110 at a proximal end 112 of main body 106. Main body106 further includes a main body distal opening 114 at a distal end 116of main body 106.

As used herein, the proximal end of a prosthesis such as single branchstent device 102 is the end closest to the heart via the path of bloodflow whereas the distal end is the end furthest away from the heartduring deployment. In contrast and of note, the distal end of thecatheter is usually identified to the end that is farthest from theoperator/handle while the proximal end of the catheter is the endnearest the operator/handle.

For purposes of clarity of discussion, as used herein, the distal end ofthe catheter is the end that is farthest from the operator (the endfurthest from the handle) while the distal end of single branch stentdevice 102 is the end nearest the operator (the end nearest the handle),i.e., the distal end of the catheter and the proximal end of singlebranch stent device 102 are the ends furthest from the handle while theproximal end of the catheter and the distal end of single branch stentdevice 102 are the ends nearest the handle. However, those of skill inthe art will understand that depending upon the access location, singlebranch stent device 102 and the delivery system descriptions may beconsistent or opposite in actual usage.

Main body 106 includes graft material 118 and one or morecircumferential stents 120 coupled to graft material 118. Graft material118 may be any suitable graft material, for example and not limited to,woven polyester, DACRON ° material, expanded polytetrafluoroethylene,polyurethane, silicone, electro spun materials, or other suitablematerials.

Circumferential stents 120 may be coupled to graft material 118 usingstitching or other means. In the embodiment shown in FIG. 1 ,circumferential stents 120 are coupled to an outside surface of graftmaterial 118. However, circumferential stents 120 may alternatively becoupled to an inside surface of graft material 118.

Although shown with a particular number of circumferential stents 120,in light of this disclosure, those of skill in the art will understandthat main body 106 may include a greater or smaller number of stents120, e.g., depending upon the desired length of main body 106 and/or theintended application thereof.

Circumferential stents 120 may be any stent material or configuration.As shown, circumferential stents 120, e.g., self-expanding members, arepreferably made from a shape memory material, such as nickel-titaniumalloy (nitinol), and are formed into a zig-zag configuration. Theconfiguration of circumferential stents 120 is merely exemplary, andcircumferential stents 120 may have any suitable configuration,including but not limiting to a continuous or non-continuous helicalconfiguration. In another embodiment, circumferential stents 120 areballoon expandable stents.

Further, main body 106 includes a longitudinal axis LA1. A lumen 122 isdefined by graft material 118, and generally by main body 106. Lumen 122extends generally parallel to longitudinal axis LA1 and between proximalopening 110 and distal opening 114 of main body 106. Graft material 118is cylindrical having a substantially uniform diameter in thisembodiment. However, in other embodiments, graft material 118 varies indiameter, e.g., flares or tapers.

Branch coupling 108 extends radially from main body 106. Branch coupling108 corresponds with an opening in main body 106. Branch coupling 108 isgenerally frustoconically shaped and includes a base 124 and a top 126.A circumference of base 124 is greater than a circumference of top 126.

Branch coupling 108 includes graft material 128 and one or morecircumferential stents 130. Graft material 128 includes any one of thegraft materials as discussed above in relation to graft material 118. Inaddition, circumferential stents 130 are similar or identical tocircumferential stents 120 as discussed above.

Further, branch coupling 108 includes a longitudinal axis LA2. A lumen132 is defined by graft material 128, and generally by branch coupling108. Lumen 132 extends generally parallel to longitudinal axis LA2 andbetween base 124 and top 126 of branch coupling 108. Lumen 132 of branchcoupling 108 is in fluid communication with lumen 122 of main body 106.

Single branch stent device 102 is deployed into aorta 104, e.g., viafemoral access. For example, to deploy single branch stent device 102, aguide wire is introduced via femoral access, i.e., is inserted into thefemoral artery and routed up through the abdominal aorta, and into thethoracic aorta.

A delivery system including single branch stent device 102 is introducedvia femoral access and is advanced into the ascending aorta 104 over theguidewire. The delivery system is positioned at the desired locationsuch that the position of single branch stent device 102 is in theascending aorta near the aortic valve AV. Single branch stent device 102is then deployed from the delivery system, e.g., by removal of a sheathconstraining single branch stent device 102.

In accordance with this embodiment, single branch stent device 102 isdeployed such that branch coupling 108 is aligned with thebrachiocephalic artery BCA. Main body 106 is located and fixed withinaorta 104 such that proximal opening 110 is proximal of thebrachiocephalic artery BCA and distal opening 114 is proximal of theleft common carotid artery LCC.

Accordingly, blood flow enters proximal opening 110 of main body 106,flows through lumen 122 of main body 106, and exits distal opening 114of main body 106 and into aorta 104 thus perfusing the distalterritories.

Further, blood flow from lumen 122 of main body 106 flows through lumen132 of branch coupling 108 and into the brachiocephalic artery BCA. Moreparticularly, blood flows enter into base 124 of branch coupling 108,through lumen 132 of branch coupling 108, and exits top 126 of branchcoupling 108 into the brachiocephalic artery BCA.

FIG. 2 is a cross-sectional view of vessel assembly 100 of FIG. 1 at alater stage during deployment of a bridging stent graft 202, sometimescalled a bridging stent, in accordance with one embodiment. Referringnow to FIG. 2 , bridging stent graft 202 is located within branchcoupling 108 and the brachiocephalic artery BCA. More particularly,bridging stent graft 202 self-expands (or is balloon expanded) to beanchored within branch coupling 108 and the brachiocephalic artery BCA.

Bridging stent graft 202 includes graft material 204 and one or morecircumferential stents 206. Graft material 204 includes any one of thegraft materials as discussed above in relation to graft material 118. Inaddition, circumferential stents 206 are similar or identical tocircumferential stents 120 as discussed above.

Upon deployment of bridging stent graft 202, blood flow into branchcoupling 108 is bridged and passed into the brachiocephalic artery BCAthrough bridging stent graft 202.

In one embodiment, bridging stent graft 202 is deployed via femoralaccess. For example, to deploy bridging stent graft 202, a guide wire isintroduced via femoral access, i.e., is inserted into the femoral arteryand routed up and into distal opening 114 of main body 106. Theguidewire is then routed through branch coupling 108 and into thebrachiocephalic artery BCA.

A delivery system including bridging stent graft 202 is introduced viafemoral access and is advanced into branch coupling 108 and thebrachiocephalic artery BCA over the guidewire. Bridging stent graft 202is then deployed from the delivery system, e.g., by removal of a sheathconstraining bridging stent graft 202.

In another embodiment, bridging stent graft 202 is deployed via supraaortic access. For example, to deploy bridging stent graft 202, a guidewire is introduced through the right subclavian artery RSA, and advancedinto main body 106 through branch coupling 108.

A delivery system including bridging stent graft 202 is introduced viasupra aortic access and is advanced into the brachiocephalic artery BCAand branch coupling 108 over the guidewire. Bridging stent graft 202 isthen deployed from the delivery system, e.g., by removal of a sheathconstraining bridging stent graft 202.

FIG. 3 is a side plan view of a modular stent device 300 in accordancewith one embodiment. FIG. 4 is a perspective view of modular stentdevice 300 of FIG. 3 in accordance with one embodiment.

Referring now to FIGS. 3 and 4 together, modular stent device 300,sometimes called a prosthesis or aortic arch prosthesis, includes a mainbody 302, a bypass gate 304 and an artery leg 306.

In accordance with this embodiment, main body 302 includes a main bodyproximal opening 308 at a proximal end 310 of main body 302. A distalend 312 of main body 302 is coupled to a proximal end 314 of bypass gate304 and a proximal end 316 of artery leg 306.

Bypass gate 304 includes a bypass gate distal opening 318 at a distalend 320 of bypass gate 304. Artery leg 306 includes a leg distal opening322 at distal end 324 of artery leg 306. Openings 318, 322 are sometimecalled distal first and second openings 318, 322, respectively.

Main body 302 includes graft material 326 and one or morecircumferential stents 328 coupled to graft material 326. Graft material326 includes any one of the graft materials as discussed above inrelation to graft material 118. In addition, circumferential stents 328are similar or identical to circumferential stents 120 as discussedabove.

Further, main body 302 includes a longitudinal axis LA1. A lumen 330 isdefined by graft material 326, and generally by main body 302. Lumen 330extends generally parallel to longitudinal axis LA1 and between proximalopening 308 and distal end 312 of main body 302. Graft material 326 iscylindrical having a substantially uniform diameter in this embodiment.However, in other embodiments, graft material 326 varies in diameter,e.g., flares or tapers.

Bypass gate 304 includes graft material 332 and one or morecircumferential stents 334 coupled to graft material 332. Graft material332 includes any one of the graft materials as discussed above inrelation to graft material 118. In addition, circumferential stents 334are similar or identical to circumferential stents 120 as discussedabove.

Further, bypass gate 304 includes a longitudinal axis LA2. A lumen 336is defined by graft material 332, and generally by bypass gate 304.Lumen 336 extends generally parallel to longitudinal axis LA2 andbetween proximal end 314 and distal opening 318 of bypass gate 304.Graft material 332 is cylindrical having a substantially uniformdiameter in this embodiment. However, in other embodiments, graftmaterial 332 varies in diameter, e.g., flares or tapers.

Artery leg 306 includes graft material 338 and one or morecircumferential stents 340 coupled to graft material 338. Graft material338 includes any one of the graft materials as discussed above inrelation to graft material 118. In addition, circumferential stents 340are similar or identical to circumferential stents 120 as discussedabove.

Further, artery leg 306 includes a longitudinal axis LA3. A lumen 342 isdefined by graft material 338, and generally by artery leg 306. Lumen342 extends generally parallel to longitudinal axis LA3 and betweenproximal end 316 and distal opening 322 of artery leg 306. Graftmaterial 338 is cylindrical having a substantially uniform diameter inthis embodiment. However, in other embodiments, graft material 338varies in diameter, e.g., includes tapered or flared configurations toaccount for patient anatomical variations. Further, limb extensions areused as needed to customize therapy to account for patient specificanatomy in one embodiment.

Generally, main body 302 is bifurcated at distal end 312 into bypassgate 304 and artery leg 306. More particularly, lumen 330 of main body302 is bifurcated into lumen 336 of bypass gate 304 and lumen 342 ofartery leg 306.

In one embodiment, graft materials 326, 332, 338 may be the same graftmaterial, e.g., may be a single piece of graft material cut and sewn.However, in other embodiments, one or more of graft materials 326, 332,338 may be different that the others of graft materials 326, 332, 338,e.g., different graft materials are cut and sewn together.

In the relaxed configuration of modular stent device 300 as illustratedin FIGS. 3 and 4 , longitudinal axes LA1, LA2, and LA3 are parallel withone another such that bypass gate 304 and artery leg 306 extend distallyfrom main body 302.

Main body 302 has a first diameter D1, bypass gate 304 has a seconddiameter D2, and artery leg 306 has a third diameter D3. In accordancewith this embodiment, first diameter D1 is greater than second diameterD2. Further, second diameter D2 is greater than third diameter D3. Inaccordance with this embodiment, first diameter D1 is greater thansecond diameter D2 combined with third diameter D3 (D1>D2+D3) such thatbypass gate 304 and artery leg 306 are located within an imaginarycylinder defined by graft material 326 of main body 302 extended in thedistal direction. The parallel design mimics anatomical blood vesselbifurcations to limit flow disruptions.

In one embodiment, first diameter D1 is greater than second diameter D2combined with third diameter D3 (D1>D2+D3) at distal end 312 andproximal ends 314, 316, sometimes called the transition region. However,main body 302, bypass gate 304 and/or artery leg 306, flare or taperaway from the transition region in accordance with another embodiment,so D1>D2+D3 at the transition region but is not necessarily correct inregions away from the transition region. Flaring is indicated by thedashed lines in FIG. 3 .

Stated another way, the transition region from main body 302 to arteryleg 306 and bypass gate 304 does not exceed first diameter D1 of mainbody 302. This insures artery leg 306 and bypass gate 304 don't crusheach other or negatively impact flow in any way. By avoiding havingartery leg 306 and bypass gate 304 extend out wider than main body 302,a good seal of stents 328 of main body 302 is insured and endoleaks areminimized or avoided.

In accordance with one embodiment, the transition region between mainbody 302 and artery leg 306 and bypass gate 304 is fully supported byone or more supporting stents, e.g., stents 328, 334, 340, to preventkinking in angled anatomy.

Main body 302 has a first length L1 in a direction parallel to thelongitudinal axis LA1, bypass gate 304 has a second length L2 in adirection parallel to the longitudinal axis LA2, and artery leg 306 hasa third length L3 in a direction parallel to the longitudinal axis LA3.In accordance with this embodiment, third length L3 is greater thansecond length L2 such that distal opening 322 the artery leg 306 isdistal to distal opening 318 of bypass gate 304. Generally, artery leg306 is longer than bypass gate 304.

Although fixed diameters D1, D2, and D3 are illustrated and discussed,in one embodiment, main body 302, bypass gate 304 and/or artery leg 306are non-uniform in diameter. For example, main body 302 flares or tapersat proximal end 310. Similarly, bypass gate 304 and/or artery leg 306flare or taper at distal ends 320, 324, respectively. For example,bypass gate 304 and/or artery leg 306 flare or taper at distal ends 320,324 to enhance sealing.

Artery leg 306 is configured to exert a higher radial force than theradial force of bypass gate 304. As used herein, “radial force” includesboth a radial force exerted during expansion/deployment as well as achronic radial force continuously exerted after implantation such that ascaffold has a predetermined compliance or resistance as the surroundingnative anatomy, e.g., the aorta 104, expands and contracts during thecardiac cycle. The radial force of bypass gate 304 is configured to belower than that of artery leg 306 to avoid collapse of artery leg 306when bypass gate 304 is deployed against and adjacent thereof and thusmaintain perfusion through artery leg 306 as discussed further below.

To configure bypass gate 304 and artery leg 306 with differing relativeradial forces, circumferential stents 340 of artery leg 306 beconstructed with relatively thicker and/or shorter segments of materialthan circumferential stents 334 of bypass gate 304. Shorter and/orthicker circumferential stents 340 have less flexibility but greaterradial force to ensure that circumferential stents 334 of bypass gate304 do not collapse lumen 342 of artery leg 306. Other variations ormodification of circumferential stents 334, 340 may be used to achieverelative radial forces in other embodiments.

Modular stent device 300 further includes radiopaque markers 350, 352,354. In accordance with this embodiment, radiopaque marker 350 is shapedas a FIG. 8 marker, i.e., in the shape of the number 8. Radiopaquemarker 350 is sewn into graft material 326 in line with artery leg 306.Under fluoroscopy, radiopaque marker 350 is rotated so that it is seenon the edge on the outer curvature of the aortic arch AA in oneembodiment so that artery leg 306 is accurately and reproduciblydeployed on the outer curve of the aorta 104.

Radiopaque maker 352 is sewn in the transition region where main body302 meets bypass gate 304 and artery leg 306 to indicate the desiredextent of overlap. Radiopaque marker 354, e.g., a coil marker, is sewninto bypass gate 304 to aid in cannulation of bypass gate 304.

FIG. 5 is a cross-sectional view of vessel assembly 100 of FIG. 2 at alater stage during deployment of modular stent device 300 of FIGS. 3 and4 in accordance with one embodiment. In accordance with this embodiment,artery leg 306 of modular stent device 300 is deployed within the leftsubclavian artery LSA via supra aortic access through the leftsubclavian artery LSA. Bypass gate 304 of modular stent device 300 islocated within aorta 104 and arranged to point away and distally fromsingle branch stent device 102. Main body 302 of modular stent device300 is located within main body 106 of single branch stent device 102and distal of branch coupling 108.

In accordance with this embodiment, blood flow enters modular stentdevice 300 from main body 106 of single branch stent device 102 throughmain body 302, and exits through bypass gate 304 and artery leg 306.Accordingly, blood flow through artery leg 306 and perfusion of the leftsubclavian artery LSA is insured. In this manner, any overlappeddiseased regions of the aorta 104 are excluded.

In accordance with this embodiment, modular stent device 300 overlaps,excludes and thus occludes the left common carotid artery LCC. Inaccordance with this embodiment, a bypass 502 provides perfusion to theleft common carotid artery LCC. Illustratively, bypass 502 providesperfusion of the left common carotid artery LCC from the left subclavianartery LSA.

Bypass 502 is surgically inserted during the same procedure asdeployment of stent devices 102, 300. However, in another embodiment,bypass 502 is surgically inserted prior to deployment of stent devices102, 300, e.g., to simplify the procedure.

FIG. 6 is a cross-sectional view of vessel assembly 100 of FIG. 5 at afinal stage during deployment of a tube graft 602 into modular stentdevice 300 and a proximal cuff 612 into single branch stent device 102in accordance with one embodiment. Referring to FIG. 6 , tube graft 602is deployed into bypass gate 304 and into aorta 104 and is attachedthereto.

Tube graft 602 includes graft material 604 and one or morecircumferential stents 606. Graft material 604 includes any one of thegraft materials as discussed above in relation to graft material 118. Inaddition, circumferential stents 606 are similar or identical tocircumferential stents 120 as discussed above.

Further, as illustrated in FIG. 6 , optionally, a proximal cuff 612 iscoupled to main body 106 of single branch stent device 102 and extendproximately therefrom. For example, proximal cuff 612 is deployed in theevent that proximal end 112 of main body 106 is deployed distally fromthe aortic valve AV to extend between the desired deployment locationand proximal end 112 of main body 106. Proximal cuff 612 is optional andin one embodiment is not deployed or used.

Proximal cuff 612 includes graft material 614 and one or morecircumferential stents 616. Graft material 614 includes any one of thegraft materials as discussed above in relation to graft material 118. Inaddition, circumferential stents 616 are similar or identical tocircumferential stents 120 as discussed above.

FIG. 7 is a cross-sectional view of vessel assembly 100 of FIG. 2 at alater stage during deployment of modular stent device 300 of FIGS. 3 and4 in accordance with another embodiment. FIG. 8 is a cross-sectionalview of vessel assembly 100 of FIG. 7 at a final stage during deploymentof tube graft 602 into modular stent device 300 and proximal cuff 612into single branch stent device 102 in accordance with one embodiment.FIGS. 7 and 8 are similar to FIGS. 5 and 6 and only the significantdifferences are discussed below.

Referring now to FIGS. 7 and 8 , artery leg 306 of modular stent device300 is deployed within the left common carotid artery LCC via supraaortic access through the left common carotid artery LCC. Accordingly,blood flow through artery leg 306 and perfusion of the left commoncarotid artery LCC is insured.

In accordance with this embodiment, tube graft 602 and/or modular stentdevice 300 overlaps, excludes and thus occludes the left subclavianartery LSA. In accordance with this embodiment, bypass 502 providesperfusion to the left subclavian artery LSA. Illustratively, bypass 502provides perfusion of the left subclavian artery LSA from the leftcommon carotid artery LCC.

FIG. 9 is a side plan view of a modular stent device 900 in accordancewith another embodiment. FIG. 10 is a perspective view of modular stentdevice 900 of FIG. 9 in accordance with one embodiment. Referring now toFIGS. 9 and 10 together, modular stent device 900 includes a main body902, a bypass gate 904 and an artery leg 906.

In accordance with this embodiment, main body 902 includes a main bodyproximal opening 908 at a proximal end 910 of main body 902. A distalend 912 of main body 902 is coupled to a proximal end 914 of bypass gate904 and a proximal end 916 of artery leg 906.

Bypass gate 904 includes a bypass gate distal opening 918 at a distalend 920 of bypass gate 904. Artery leg 906 includes a leg distal opening922 at a distal end 924 of artery leg 906. Openings 918, 922 aresometime called distal first and second openings 918, 922, respectively.

Main body 902 includes graft material 926 and one or morecircumferential stents 928 coupled to graft material 926. Graft material926 includes any one of the graft materials as discussed above inrelation to graft material 118. In addition, circumferential stents 928are similar or identical to circumferential stents 120 as discussedabove.

Further, main body 902 includes a longitudinal axis LA1. A lumen 930 isdefined by graft material 926, and generally by main body 902. Lumen 930extends generally parallel to longitudinal axis LA1 and between proximalopening 908 and distal end 912 of main body 902. Graft material 926 iscylindrical having a substantially uniform diameter in this embodiment.However, in other embodiments, graft material 926 varies in diameter,e.g., flares or tapers.

Bypass gate 904 includes graft material 932 and one or morecircumferential stents 934 coupled to graft material 932. Graft material932 includes any one of the graft materials as discussed above inrelation to graft material 118. In addition, circumferential stents 934are similar or identical to circumferential stents 120 as discussedabove.

Further, bypass gate 904 includes a longitudinal axis LA2. A lumen 936is defined by graft material 932, and generally by bypass gate 904.Lumen 936 extends generally parallel to longitudinal axis LA2 andbetween proximal end 914 and distal opening 918 of bypass gate 904.Graft material 932 is cylindrical having a substantially uniformdiameter in this embodiment. However, in other embodiments, graftmaterial 932 varies in diameter, e.g., tapers or flares.

Artery leg 906 includes graft material 938 and one or morecircumferential stents 940 coupled to graft material 938. Graft material938 includes any one of the graft materials as discussed above inrelation to graft material 118. In addition, circumferential stents 940are similar or identical to circumferential stents 120 as discussedabove.

Further, artery leg 906 includes longitudinal axis LA3. A lumen 942 isdefined by graft material 938, and generally by artery leg 906. Lumen942 extends generally parallel to longitudinal axis LA3 and betweenproximal end 916 and distal opening 922 of artery leg 906. Graftmaterial 938 is cylindrical having a substantially uniform diameter inthis embodiment. However, in other embodiments, graft material 938varies in diameter, e.g., flares or tapers.

Generally, main body 902 is bifurcated at distal end 912 into bypassgate 904 and artery leg 906. More particularly, lumen 930 of main body902 is bifurcated into lumen 936 of bypass gate 904 and lumen 942 ofartery leg 906. In one embodiment, graft materials 926, 932, 938 may bethe same graft material, e.g., may be a single piece of graft materialcut and sewn. However, in other embodiments, one or more of graftmaterials 926, 932, 938 may be different that the others of graftmaterials 926, 932, 938, e.g., different graft materials are cut andsewn together.

In the relaxed configuration (unstressed) of modular stent device 900 asillustrated in FIGS. 9 and 10 , longitudinal axes LA1, LA2, and LA3 areparallel with one another such that bypass gate 904 and artery leg 906extend distally from main body 902.

Main body 902 has first diameter D1, bypass gate 904 has second diameterD2, and artery leg 906 has third diameter D3. In accordance with thisembodiment, first diameter D1 is greater than second diameter D2.Further, second diameter D2 is greater than third diameter D3. Inaccordance with this embodiment, first diameter D1 is greater thansecond diameter D2 combined with third diameter D3 (D1>D2+D3) such thatbypass gate 904 and artery leg 906 are located within an imaginarycylinder defined by graft material 926 of main body 902 extended in thedistal direction. The parallel design mimics anatomical blood vesselbifurcations to limit flow disruptions.

In one embodiment, first diameter D1 is greater than second diameter D2combined with third diameter D3 (D1>D2+D3) at distal end 912 andproximal ends 914, 916, sometimes called the transition region. However,main body 902, bypass gate 904 and/or artery leg 906, flare or taperaway from the transition region in accordance with one embodiment, soD1>D2+D3 at the transition region but is not necessarily correct inregions away from the transition region. Flaring is indicated by thedashed lines in FIG. 9 .

Stated another way, the transition region from main body 902 to arteryleg 906 and bypass gate 904 does not exceed first diameter D1 of mainbody 902. This insures artery leg 906 and bypass gate 904 don't crusheach other or negatively impact flow in any way. By avoiding havingartery leg 906 and bypass gate 904 extend out wider than main body 902,a good seal of stents 928 of main body 902 is insured and endoleaks areminimized or avoided.

In accordance with one embodiment, the transition region between mainbody 902 and artery leg 906 and bypass gate 904 is fully supported byone or more supporting stents, e.g., stents 928, 934, 940, to preventkinking in angled anatomy.

Main body 902 has a first length L1 in a direction parallel to thelongitudinal axis LA1, bypass gate 904 has a second length L2 in adirection parallel to the longitudinal axis LA2, and artery leg 906 hasa third length L3 in a direction parallel to the longitudinal axis LA3.In accordance with this embodiment, third length L3 is less than secondlength L2 such that distal opening 922 of artery leg 906 is proximal todistal opening 918 of bypass gate 904. Generally, artery leg 906 isshorter than bypass gate 904.

Although fixed diameters D1, D2, and D3 are illustrated and discussed,in one embodiment, main body 902, bypass gate 904 and/or artery leg 906are non-uniform in diameter. For example, main body 902 flares or tapersat proximal end 910. Similarly, bypass gate 904 and/or artery leg 906flare or taper at distal ends 920, 924, respectively. For example,bypass gate 904 and/or artery leg 906 flare or taper at distal ends 920,924 to enhance sealing.

Artery leg 906 is configured to exert a higher radial force than theradial force of bypass gate 904. The radial force of bypass gate 904 isconfigured to be lower than that of artery leg 906 order to avoidcollapse of artery leg 906 when bypass gate 904 is deployed against andadjacent thereof and thus maintain perfusion of artery leg 906 asdiscussed further below.

To configure bypass gate 904 and artery leg 906 with differing relativeradial forces, circumferential stents 940 of artery leg 906 beconstructed with relatively thicker and/or shorter segments of materialthan circumferential stents 934 of bypass gate 904. Shorter and/orthicker circumferential stents 940 have less flexibility but greaterradial force to ensure that circumferential stents 934 of bypass gate904 do not collapse lumen 942 of artery leg 906. Other variations ormodification of circumferential stents 934, 940 may be used to achieverelative radial forces in other embodiments.

Modular stent device 900 includes radiopaque markers 950, 952, 954. Inaccordance with this embodiment, radiopaque marker 950 is shaped as aFIG. 8 marker, i.e., in the shape of the number 8. Radiopaque marker 950is sewn into graft material 926 in line with artery leg 906. Underfluoroscopy, radiopaque marker 950 is rotated so that it is seen on theedge on the outer curvature of the aortic arch in one embodiment so thatartery leg 906 is accurately and reproducibly deployed on the outercurve of the aorta 104.

Radiopaque maker 952 is sewn in the transition region where main body902 meets bypass gate 904 and artery leg 906 to indicate the desiredextent of overlap. Radiopaque marker 954, e.g., a coil marker, is sewninto bypass gate 904 to aid in cannulation of bypass gate 904.

FIG. 11 is a cross-sectional view of vessel assembly 100 of FIG. 2 at alater stage during deployment of modular stent device 900 of FIGS. 9 and10 in accordance with another embodiment.

In accordance with this embodiment, modular stent device 900 is deployedwithin main body 106 of single branch stent device 102 via femoralaccess. For example, to deploy modular stent device 900, a guide wire isintroduced via femoral access, i.e., is inserted into the femoral arteryand routed up through the abdominal aorta, and into main body 106 ofsingle branch stent device 102.

A delivery system including modular stent device 900 is introduced viafemoral access and is advanced into main body 106 of single branch stentdevice 102 over the guidewire. The delivery system is positioned at thedesired location. Modular stent device 900 is then deployed from thedelivery system, e.g., by removal of a sheath constraining modular stentdevice 900.

More particularly, bypass gate 904 of modular stent device 900 islocated within aorta 104 and arranged to point away and distally fromsingle branch stent device 102. Main body 902 of modular stent device900 is located within main body 106 of single branch stent device 102and distal of branch coupling 108. Distal opening 922 of artery leg 906is proximal of both the left common carotid artery LCC and the leftsubclavian artery LSA.

FIG. 12 is a cross-sectional view of vessel assembly 100 of FIG. 11 at alater stage during deployment of a bridging stent graft 1202, sometimescalled a bridging stent, in accordance with one embodiment. Referring toFIGS. 11 and 12 together, bridging stent graft 1202 is deployed withinartery leg 906 and the left subclavian artery LSA. More particularly,bridging stent graft 1202 self-expands (or is balloon expanded) to beanchored within artery leg 906 and the left subclavian artery LSA.Bridging stent graft 1202 is deployed via supra aortic access throughthe left subclavian artery LSA or is deployed via femoral access.

Bridging stent graft 1202 includes graft material 1204 and one or morecircumferential stents 1206. Upon deployment of bridging stent graft1202, blood flow into artery leg 906 is bridged and passed into the leftsubclavian artery LSA through bridging stent graft 1202. In this manner,any overlapped diseased regions of the aorta 104 are excluded.

In accordance with this embodiment, modular stent device 900 and/orbridging stent graft 1202 overlaps, excludes and thus occludes the leftcommon carotid artery LCC. In accordance with this embodiment, bypass502 provides perfusion to the left common carotid artery LCC.Illustratively, bypass 502 provides perfusion of the left common carotidartery LCC from the left subclavian artery LSA.

FIG. 13 is a cross-sectional view of vessel assembly 100 of FIG. 12 at afinal stage during deployment of a tube graft 1302 into modular stentdevice 900 and proximal cuff 612 into single branch stent device 102 inaccordance with one embodiment. Referring to FIG. 13 , tube graft 1302is deployed into bypass gate 904 and into aorta 104 and is attachedthereto.

Tube graft 1302 includes graft material 1304 and one or morecircumferential stents 1306. Graft material 1304 includes any one of thegraft materials as discussed above in relation to graft material 118. Inaddition, circumferential stents 1306 are similar or identical tocircumferential stents 120 as discussed above.

Further, as illustrated in FIG. 13 , optionally, proximal cuff 612 iscoupled to main body 106 of single branch stent device 102 and extendproximately therefrom in a manner similar to that discussed aboveregarding FIG. 6 , and so is not repeated here for simplicity.

FIG. 14 is a cross-sectional view of vessel assembly 100 of FIG. 11 at alater stage during deployment of a bridging stent graft 1402 inaccordance with another embodiment.

Referring to FIGS. 11 and 14 together, bridging stent graft 1402 isdeployed within artery leg 906 and the left common carotid artery LCC.More particularly, bridging stent graft 1402 self-expands (or is balloonexpanded) to be anchored within artery leg 906 and the left commoncarotid artery LCC. Bridging stent graft 1402 is deployed via supraaortic access through the left common carotid artery LCC or throughfemoral access in a manner similar to that discussed above regardingdeployment of bridging stent graft 1202.

Bridging stent graft 1402 includes graft material 1404 and one or morecircumferential stents 1406. Upon deployment of bridging stent graft1402, blood flow into artery leg 906 is bridged and passed into the leftcommon carotid artery LCC through bridging stent graft 1402. In thismanner, any overlapped diseased regions of the aorta 104 are excluded.

In accordance with this embodiment, modular stent device 900 and/orbridging stent graft 1402 overlaps, excludes and thus occludes the leftsubclavian artery LSA. In accordance with this embodiment, bypass 502provides perfusion to the left subclavian artery LSA. Illustratively,bypass 502 provides perfusion of the left subclavian artery LSA from theleft common carotid artery LCC.

FIG. 15 is a cross-sectional view of vessel assembly 100 of FIG. 14 at afinal stage during deployment of tube graft 1302 into modular stentdevice 900 and proximal cuff 612 into single branch stent device 102 inaccordance with one embodiment. Referring to FIG. 15 , tube graft 1302is deployed into bypass gate 904 and into aorta 104 and is attachedthereto. Further, as illustrated in FIG. 15 , optionally, proximal cuff612 is coupled to main body 106 of single branch stent device 102 andextend proximately therefrom. Tube graft 1302 and proximal cuff 612, andthe deployment thereof, are similar to that discussed above in regardsto FIG. 13 , and so is not repeated here for simplicity.

FIG. 16 is a cross-sectional view of a vessel assembly 100A similar tovessel assembly 100 of FIG. 6 in accordance with another embodiment.Referring now to FIG. 16 , to increase and/or provide sufficient overlapbetween single branch device 102 and main body 302 of modular stentdevice 300, main body 106 extends distally past the brachiocephalicartery BCA, for example, distally past the left common carotid arteryLCC. This provides additional overlap area within main body 106 distallypast branch coupling 108 for the modular connection between singlebranch device 102 and modular stent device 300 to withstand dynamicmotion of the aortic arch AA.

Further, as illustrated in FIG. 6 , bypass gate 304 flares to seal inthe aorta 104. However, in FIG. 16 , bypass gate 304 is shorter thanillustrated in FIG. 6 , e.g., is at or near the left subclavian arteryLSA and tube graft 602 provides the seal with aorta 104.

FIG. 17 is a cross-sectional view of a region of the vessel assembly 100of FIG. 2 with branch coupling 108 misaligned with the brachiocephalicartery BCA in accordance with one embodiment. Referring now to FIG. 17 ,to increase and/or provide sufficient overlap between single branchdevice 102 and main body 302 of modular stent device 300, branchcoupling 108 is located proximally to the brachiocephalic artery BCA.Bridging stent graft 202 bridges the displacement between branchcoupling 108 and the brachiocephalic artery BCA. This providesadditional overlap area within main body 106 distally past branchcoupling 108 for the modular connection between single branch device 102and modular stent device 300 to withstand dynamic motion of the aorticarch AA.

This Application is related to: U.S. patent application Ser. No.16/367,889, filed on Mar. 28, 2019, and issued as U.S. Pat. No.11,304,794 on Apr. 19, 2022; U.S. patent application Ser. No.16/367,906, filed on Mar. 28, 2019 and issued as U.S. Pat. No.11,116,650 on Sep. 14, 2021; U.S. patent application Ser. No.16/367,922, filed on Mar. 28, 2019, and issued as U.S. Pat. No.11,083,605 on Aug. 10, 2021; and U.S. Pat. No. 9,839,542, issued on Dec.12, 2017, the disclosures of which are herein incorporated by referencein their entireties.

It should be understood that various aspects disclosed herein may becombined in different combinations than the combinations specificallypresented in the description and accompanying drawings. It should alsobe understood that, depending on the example, certain acts or events ofany of the processes or methods described herein may be performed in adifferent sequence, may be added, merged, or left out altogether (e.g.,all described acts or events may not be necessary to carry out thetechniques). In addition, while certain aspects of this disclosure aredescribed as being performed by a single module or unit for purposes ofclarity, it should be understood that the techniques of this disclosuremay be performed by a combination of units or modules associated with,for example, a medical device.

What is claimed is:
 1. A stent graft assembly comprising: a singlebranch stent device including a main body and a branch couplingextending radially from the main body, the single branch stent deviceincludes a proximal end and a distal end, the proximal end of the singlebranch stent device is configured to seal in an ascending portion of anaorta; a modular stent device including a proximal end and a distal end,the proximal end of the modular stent graft is configured to couple to adistal end of the single branch stent device, the modular stent deviceincludes a main body configured to couple inside the main body of thesingle branch stent device, the modular stent device includes a bypassgate and an artery leg, the modular stent device is configured tobifurcate at a bifurcation point from the main body to the bypass gateand the artery leg outside of and distal the distal end of the singlebranch stent device.
 2. The stent graft assembly of claim 1, wherein theartery leg is configured to engage the aorta.
 3. The stent graftassembly of claim 1, wherein the bypass gate is configured to engage theaorta.
 4. The stent graft assembly of claim 1, wherein the artery leg isconfigured to contact the bypass gate.
 5. The stent graft assembly ofclaim 1, wherein the bifurcation point does not engage the aorta.
 6. Thestent graft assembly of claim 1, wherein the bifurcation point isconfigured to align between first and second branches of the aorta. 7.The stent graft assembly of claim 6, wherein the first branch is abrachiocephalic artery and the second branch is a left common carotid.8. The stent graft assembly of claim 1, wherein the artery leg isconfigured to terminate proximal a left common carotid artery.
 9. Thestent graft assembly of claim 1 further comprising a bridging stentgraft configured to couple to the artery leg.
 10. The stent graftassembly of claim 8, wherein the bridging stent graft is configured toextend into the left common carotid artery.
 11. The stent graft assemblyof claim 8, wherein the bridging stent graft is configured to extendinto the left subclavian artery.
 12. The stent graft assembly of claim 1further comprising a tube graft configured to couple to the bypass gateand extend distally therefrom.
 13. A method comprising: introducing asingle branch stent device via femoral access; advancing the singlebranch stent device into the ascending aorta; deploying the singlebranch stent device; introducing a modular stent device via accessthrough an artery distal of the brachiocephalic artery; advancing themodular stent device such that a main body of the modular stent deviceis located within the main body of the single branch stent device; anddeploying the modular stent device such that the main body of themodular stent device bifurcates at a bifurcation point to the bypassgate and the artery leg outside of and distal the distal end of thesingle branch stent device.
 14. The method of claim 13 furthercomprising deploying a bridging stent graft within the branch couplingand the brachiocephalic artery.
 15. The method of claim 13, wherein theartery distal of the brachiocephalic artery is selected from the groupconsisting of the left common carotid artery and the left subclavianartery.
 16. The method of claim 13 further comprising engaging the aortawith the artery leg.
 17. The method of claim 13 further comprisingengaging the aorta with the bypass gate.
 18. The method of claim 13further comprising contacting the bypass gate and the artery legradially inward the aorta.